EPLERENONE TEVA 50 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
EPLERENONE
Available from:
Teva Pharma B.V.
INN (International Name):
EPLERENONE
Dosage:
50 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2014-04-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eplerenone Teva 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of eplerenone.
_Excipient with known effect_
Each 50 mg film-coated tablet contains 76 mg of lactose monohydrate (equivalent to 73 mg of lactose anhydrous) (see
section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, diamond-shaped, biconvex film-coated tablet, approximately 8.0 mm wide and 9.5 mm long, engraved with
“E50” on one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eplerenone is indicated:
In addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and
morbidity in stable patients with left ventricular dysfunction (LVEF 40%) and clinical evidence of heart failure
after recent myocardial infarction.
In addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult
patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF 30%) (see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For the individual adjustment of dose, the strengths of 25 mg and 50 mg are available.
The maximum dose regimen is 50 mg daily.
_For post-myocardial infarction heart failure patients:_
The recommended maintenance dose of eplerenone is 50 mg once daily (OD). Treatment should be initiated at 25 mg
once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks, taking into account the serum
potassium level (see table 1). Eplerenone therapy should usually be started within 3-14 days after an acute myocardial
infarction.
_For patients with NYHA class II (
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